BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 3133428 · Received May 29, 2013

    Report

    Report Number
    0001811755-2013-01224
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 28, 2013
    Report Date
    May 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REAR MOTOR WINDING WAS FOUND TO HAVE A SHORT CIRCUIT. A SHORT CIRCUIT CAN CAUSE AN INCREASED CURRENT DRAW, WHICH CAN RESULT IN OVERHEATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE, THE HANDPIECE WAS OVERHEATING. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236011 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1